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A First In Man Phase I Study Of EPC2407, A Microtubule Inhibitor Anti-Cancer Drug With Tumor Vascular Endothelial Disrupting Activity: Intravenous Administration Daily For Three Days In Patients With Advanced Solid Tumors And Lymphomas

Trial Information

A First In Man Phase I Study Of EPC2407, A Microtubule Inhibitor Anti-Cancer Drug With Tumor Vascular Endothelial Disrupting Activity: Intravenous Administration Daily For Three Days In Patients With Advanced Solid Tumors And Lymphomas

This is a Phase I, open label, multicenter, dose-escalation, safety, pharmacokinetic, and
pharmacodynamic study of EPC2407 administered intravenously over 60 minutes on a QDx3
schedule repeated every 21 days. Patients are enrolled and dosed at the level defined by the
escalation scheme. The primary goal of the study design is to assess toxicity at the fixed
dose levels according to the modified Fibonacci schema.

Inclusion Criteria:

1. Histologically or cytologically confirmed solid tumor or lymphoma,which has
progressed on standard therapies, for which effective therapy is not available or for
patients who are unwilling to undergo such therapies.

8. For men and women of child-producing potential - willingness to employ appropriate
contraceptive methods (including abstinence) during the study

9. Ability to understand the requirements of the study, provide written informed consent
and authorization of use and disclosure of protected health information, and agree to
abide by the study restrictions and to return for the required assessments

2. Radiotherapy or any chemotherapy within the previous 21 days or five half lives of
prior drug (whichever is shorter). See also exclusion #4 below for patients at risk
for cardiac toxicity. Recovery to Grade 1 or less from chemotherapy-induced toxic
effect, except alopecia, is required.

3. Major surgery within the last 4 weeks or minor surgery within the last 2 weeks

4. Significant risk of cardiac drug toxicity due to any of the following: a) Active New
York Heart Association Class III or IV, b) history of or current congestive heart
failure, c) history of myocardial infarction within the last 6 months or ongoing
unstable angina, or anthracycline exposure per exclusion #5.

5. Anthracycline exposure exceeding a cumulative dose of 360 mg/m²

6. Known and ongoing HIV, Hepatitis B or Hepatitis C infection

7. Concomitant use of strong inhibitors of the liver microsomal enzymes CYP2C8, CYP2C9,
CYP2C19 and CYP3A4.

8. Participation in concurrent study of an investigational agent or device

9. Any other condition including but not limited to major co-morbidities, which in the
opinion of the investigator would render the patient ineligible

10. O2 Saturation by pulse oximetry at rest < 90%

11. Concomitant use of drugs that have significant risk of Torsades de Pointes will also
be prohibited. Please refer to drugs listed under "Drugs with Risk of Torsades de
Pointes"

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